- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02630706
A Study to Evaluate the Efficacy and Safety of Ertugliflozin in Asian Participants With Type 2 Diabetes and Inadequate Glycemic Control on Metformin Monotherapy (MK-8835-012)
November 13, 2018 updated by: Merck Sharp & Dohme LLC
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 26-Week Multicenter Study to Evaluate the Efficacy and Safety of Ertugliflozin in Asian Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Metformin Monotherapy (VERTIS-ASIA)
This is a study to evaluate the efficacy and safety of the addition of ertugliflozin to metformin monotherapy in Asian participants with Type 2 diabetes mellitis (T2DM) who have inadequate glycemic control on metformin monotherapy.
The primary hypothesis is that the mean reduction from baseline in HbA1C for 15 mg and 5 mg ertugliflozin (tested sequentially) is greater than for placebo.
Study Overview
Status
Completed
Conditions
Detailed Description
This study includes a 1-week screening period, an 8-week (or greater) antihyperglycemic agent (AHA) wash-off and/or metformin dose stable period (as necessary), a 2-week single-blind placebo run-in period, a 26-week double-blind treatment period, and a post-treatment telephone contact 14 days after the last dose of study drug.
Study Type
Interventional
Enrollment (Actual)
506
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Asian participants ≥18 years of age at the time of initial Screening.
- Type 2 diabetes mellitus as per American Diabetes Association guidelines.
- Metformin monotherapy (≥1500 mg/day) with an initial Screening A1C of 7.0-10.5% (53-91 mmol/mol) OR metformin monotherapy (<1500 mg/day) with an initial Screening A1C of 7.5-11.0% (58-97 mmol/mol) OR dual combination therapy with metformin + sulfonylurea, dipeptidyl peptidase-4 (DDP-4) inhibitor, meglitinide, or alpha-glucosidase inhibitor with an initial Screening A1C of 6.5-9.5% (48-80 mmol/mol).
- Body mass index (BMI) ≥18.0 kg/m^2.
- Male or female not of reproductive potential.
- Female of reproductive potential who agrees to remain abstinent from heterosexual activity or to use 2 acceptable combinations of contraception.
Exclusion Criteria:
- History of type 1 diabetes mellitus or a history of ketoacidosis.
- History of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant.)
- History of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, or New York Heart Association (NYHA) functional class III-IV heart failure within 3 months of study start.
- Mean value for triplicate screening sitting systolic blood pressure >160 mm Hg and/or diastolic blood pressure >90 mm Hg after at least a 5-minute seated rest at screening
- Active, obstructive uropathy or indwelling urinary catheter.
- History of malignancy ≤5 years prior to study start, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week or engages in binge drinking.
- Any clinically significant malabsorption condition.
- Is on a weight-loss program or weight-loss medication or other medication associated with weight changes and is not weight stable prior to study start.
- Has undergone bariatric surgery within the past 12 months or >12 months and is not weight stable prior to study start.
- A known hypersensitivity or intolerance to any sodium glucose co-transporter (SGLT2) inhibitor.
- On a previous clinical study with ertugliflozin.
- Is taking blood pressure or lipid altering medications that have not been on a stable dose for at least 4 weeks prior to study start.
- Current treatment for hyperthyroidism.
- Male participants with a serum creatinine >=1.3 mg/dL (>=115 mol/L) or female participants with a serum creatinine >=1.2 mg/dL (>=106 mol/L) or participants with an estimated glomerular filtration rate (eGFR) <55 mL/min/1.73m^2 according to the 4-variable Modification of Diet in Renal Disease (MDRD) equation at screening.
- An aspartate transaminase (AST) or alanine transaminase (ALT) >2X the upper limit of normal (ULN) range at screening, or a total bilirubin >1.5 X the ULN unless the participant has a history of Gilbert's.
- On thyroid replacement therapy and has not been on a stable dose for at least 6 weeks prior to study start.
- A medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease.
- Has been treated with any of the following agents within 12 weeks of study start or during the pre-randomization period: Insulin of any type (except for short-term use during concomitant illness or other stress), other injectable anti-hyperglycemic agents (e.g., pramlintide, exenatide, liraglutide), another SGLT2 inhibitor, bromocriptine, colesevelam, rosiglitazone or pioglitazone, or any other AHA with the exception of the protocol-approved agents.
- Is on or likely to require treatment ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.
- Has undergone a surgical procedure within 6 weeks prior to study start or has planned major surgery during the study.
- Pregnant or breast-feeding, or planning to conceive during the trial, including 14 days following the last dose of study medication.
- Planning to undergo hormonal therapy in preparation for egg donation during the trial, including 14 days following the last dose of study medication.
- Donated blood or blood products within 6 weeks of study start.
- Has Human Immunodeficiency Virus (HIV).
- Has blood dyscrasias or any disorders causing hemolysis or unstable red blood cells.
- Has clinically important hematological disorders (such as aplastic anemia, myeloproliferative or myelodyplastic syndromes, thrombocytopenia.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ertugliflozin 5 mg
Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day).
Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values.
|
Ertugliflozin 5 mg oral tablet taken once daily
Other Names:
Placebo matching ertugliflozin (5-mg and/or 10-mg tablet) oral taken once daily
Participants are to remain on their stable doses of metformin (oral, >=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period.
Participants on metformin <1500 at screening are up-titrated to >= 1500 daily.
Glycemic rescue therapy with open-label glimepiride will be initiated in participants with glucose values exceeding protocol-specified values.
Dosing and titration of open-label glimepiride rescue therapy will be at the Investigator's discretion.
|
Experimental: Ertugliflozin 15 mg
Ertugliflozin 15 mg (ertugliflozin 5 mg + ertugliflozin 10 mg) administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day).
Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values.
|
Participants are to remain on their stable doses of metformin (oral, >=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period.
Participants on metformin <1500 at screening are up-titrated to >= 1500 daily.
Glycemic rescue therapy with open-label glimepiride will be initiated in participants with glucose values exceeding protocol-specified values.
Dosing and titration of open-label glimepiride rescue therapy will be at the Investigator's discretion.
Ertugliflozin 15 mg (5-mg and 10-mg tablets) oral taken once daily
Other Names:
|
Placebo Comparator: Placebo
Placebo matching ertugliflozin administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day).
Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values.
|
Placebo matching ertugliflozin (5-mg and/or 10-mg tablet) oral taken once daily
Participants are to remain on their stable doses of metformin (oral, >=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period.
Participants on metformin <1500 at screening are up-titrated to >= 1500 daily.
Glycemic rescue therapy with open-label glimepiride will be initiated in participants with glucose values exceeding protocol-specified values.
Dosing and titration of open-label glimepiride rescue therapy will be at the Investigator's discretion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in A1C (%) at Week 26 (Excluding Rescue Approach)
Time Frame: Baseline and Week 26
|
A1C is blood marker used to report average blood glucose levels over prolonged periods of time.
Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.
Thus, this change from baseline reflects the Week 26 A1C minus the Week 0 A1C (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis).
Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
|
Baseline and Week 26
|
Change From Baseline in A1C (%) at Week 26 (Excluding Rescue Approach) (China Subpopulation)
Time Frame: Baseline and Week 26
|
A1C is blood marker used to report average blood glucose levels over prolonged periods of time.
Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.
Thus, this change from baseline reflects the Week 26 A1C minus the Week 0 A1C (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis).
Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
|
Baseline and Week 26
|
Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach)
Time Frame: Up to 28 weeks
|
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
Up to 28 weeks
|
Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach) (China Subpopulation)
Time Frame: Up to 28 weeks
|
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
Up to 28 weeks
|
Percentage of Participants Discontinuing Study Treatment Due to an AE (Including Rescue Approach)
Time Frame: Up to 26 weeks
|
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
Up to 26 weeks
|
Percentage of Participants Discontinuing Study Treatment Due to an AE (Including Rescue Approach) (China Subpopulation)
Time Frame: Up to 26 weeks
|
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
Up to 26 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Fasting Plasma Glucose at Week 26 (Excluding Rescue Approach)
Time Frame: Baseline and Week 26
|
Blood glucose was measured on a fasting basis.
Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at Week 0) which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis.
Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
|
Baseline and Week 26
|
Change From Baseline in Fasting Plasma Glucose at Week 26 (Excluding Rescue Approach) (China Subpopulation)
Time Frame: Baseline and Week 26
|
Blood glucose was measured on a fasting basis.
Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at Week 0) which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis.
Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
|
Baseline and Week 26
|
Change From Baseline in Body Weight at Week 26 (Excluding Rescue Approach)
Time Frame: Baseline and Week 26
|
The change in body weight from baseline reflects the Week 26 body weight minus the Week 0 body weight (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis).
Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
|
Baseline and Week 26
|
Change From Baseline in Body Weight at Week 26 (Excluding Rescue Approach) (China Subpopulation)
Time Frame: Baseline and Week 26
|
The change in body weight from baseline reflects the Week 26 body weight minus the Week 0 body weight (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis).
Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
|
Baseline and Week 26
|
Percentage of Participants With HbA1c of <7.0% (53 mmol/Mol) (Logistic Regression Using Multiple Imputation Based on cLDA Model: Excluding Rescue Approach)
Time Frame: Week 26
|
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%).
Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.
Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
|
Week 26
|
Percentage of Participants With HbA1c of <7.0% (53 mmol/Mol) (Logistic Regression Using Multiple Imputation Based on cLDA Model: Excluding Rescue Approach) (China Subpopulation)
Time Frame: Week 26
|
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%).
Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.
Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
|
Week 26
|
Change From Baseline in Sitting Systolic Blood Pressure at Week 26 (Excluding Rescue Approach)
Time Frame: Baseline and Week 26
|
This change from baseline reflects the Week 26 sitting systolic blood pressure (SBP) minus the Week 0 sitting SBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis).
Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
|
Baseline and Week 26
|
Change From Baseline in Sitting Systolic Blood Pressure at Week 26 (Excluding Rescue Approach) (China Subpopulation)
Time Frame: Baseline and Week 26
|
This change from baseline reflects the Week 26 sitting systolic blood pressure (SBP) minus the Week 0 sitting SBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis).
Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
|
Baseline and Week 26
|
Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 (Excluding Rescue Approach)
Time Frame: Baseline and Week 26
|
This change from baseline reflects the Week 26 sitting diastolic blood pressure (DBP) minus the Week 0 sitting DBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis).
Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
|
Baseline and Week 26
|
Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 (Excluding Rescue Approach) (China Subpopulation)
Time Frame: Baseline and Week 26
|
This change from baseline reflects the Week 26 sitting diastolic blood pressure (DBP) minus the Week 0 sitting DBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis).
Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
|
Baseline and Week 26
|
Percentage of Participants With HbA1c of <6.5% (48 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach)
Time Frame: Week 26
|
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%).
Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.
Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
|
Week 26
|
Percentage of Participants With HbA1c of <6.5% (48 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach) (China Subpopulation)
Time Frame: Week 26
|
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%).
Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.
Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
|
Week 26
|
Percentage of Participants Requiring Glycemic Rescue Therapy Through Week 26.
Time Frame: Week 26
|
Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
|
Week 26
|
Percentage of Participants Requiring Glycemic Rescue Therapy Through Week 26 (China Subpopulation)
Time Frame: Week 26
|
Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
|
Week 26
|
Time to Glycemic Rescue Therapy
Time Frame: Up to 183 days
|
Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
|
Up to 183 days
|
Time to Glycemic Rescue Therapy (China Subpopulation)
Time Frame: Up to 149 days
|
Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
|
Up to 149 days
|
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach
Time Frame: Week 6: Pre-Dose
|
No ertugliflozin plasma concentrations were determined for participants receiving placebo.
Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
|
Week 6: Pre-Dose
|
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach
Time Frame: Week 12: Pre-Dose
|
No ertugliflozin plasma concentrations were determined for participants receiving placebo.
Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
|
Week 12: Pre-Dose
|
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach
Time Frame: Week 12: 60 min. Post-Dose
|
No ertugliflozin plasma concentrations were determined for participants receiving placebo.
Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
|
Week 12: 60 min. Post-Dose
|
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach
Time Frame: Week 18: Pre-Dose
|
No ertugliflozin plasma concentrations were determined for participants receiving placebo.
Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
|
Week 18: Pre-Dose
|
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach
Time Frame: Week 18: 60 min. Post-Dose
|
No ertugliflozin plasma concentrations were determined for participants receiving placebo.
Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
|
Week 18: 60 min. Post-Dose
|
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach
Time Frame: Week 26: Pre-Dose
|
No ertugliflozin plasma concentrations were determined for participants receiving placebo.
Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
|
Week 26: Pre-Dose
|
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)
Time Frame: Week 6: Pre-Dose
|
No ertugliflozin plasma concentrations were determined for participants receiving placebo.
Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
|
Week 6: Pre-Dose
|
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)
Time Frame: Week 12: Pre-Dose
|
No ertugliflozin plasma concentrations were determined for participants receiving placebo.
Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
|
Week 12: Pre-Dose
|
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)
Time Frame: Week 12: 60 min. Post-Dose
|
No ertugliflozin plasma concentrations were determined for participants receiving placebo.
Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
|
Week 12: 60 min. Post-Dose
|
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)
Time Frame: Week 18: Pre-Dose
|
No ertugliflozin plasma concentrations were determined for participants receiving placebo.
Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
|
Week 18: Pre-Dose
|
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)
Time Frame: Week 18: 60 min. Post-Dose
|
No ertugliflozin plasma concentrations were determined for participants receiving placebo.
Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
|
Week 18: 60 min. Post-Dose
|
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)
Time Frame: Week 26: Pre-Dose
|
No ertugliflozin plasma concentrations were determined for participants receiving placebo.
Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
|
Week 26: Pre-Dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Fediuk DJ, Sahasrabudhe V, Dawra VK, Zhou S, Sweeney K. Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1297-1306. doi: 10.1002/cpdd.970. Epub 2021 Jul 2.
- Xu H, O'Gorman MT, Nepal S, James LP, Ginman K, Pithavala YK. Phase 1 Study Evaluating the Effects of the Proton Pump Inhibitor Rabeprazole and Food on the Pharmacokinetics of Lorlatinib in Healthy Participants. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1395-1404. doi: 10.1002/cpdd.1000. Epub 2021 Jul 20.
- Ji L, Liu Y, Miao H, Xie Y, Yang M, Wang W, Mu Y, Yan P, Pan S, Lauring B, Liu S, Huyck S, Qiu Y, Terra SG. Safety and efficacy of ertugliflozin in Asian patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy: VERTIS Asia. Diabetes Obes Metab. 2019 Jun;21(6):1474-1482. doi: 10.1111/dom.13681. Epub 2019 Apr 5.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 16, 2015
Primary Completion (Actual)
December 27, 2017
Study Completion (Actual)
December 27, 2017
Study Registration Dates
First Submitted
December 11, 2015
First Submitted That Met QC Criteria
December 11, 2015
First Posted (Estimate)
December 15, 2015
Study Record Updates
Last Update Posted (Actual)
December 7, 2018
Last Update Submitted That Met QC Criteria
November 13, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Immunosuppressive Agents
- Immunologic Factors
- Sodium-Glucose Transporter 2 Inhibitors
- Metformin
- Glimepiride
- Ertugliflozin
Other Study ID Numbers
- 8835-012
- B1521045 (Other Identifier: Pfizer Protocol Number)
- MK-8835-012 (Other Identifier: Merck Protocol Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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